Regulatory Watch

Regulating Cannabis-Based Medicines in Europe

June 02, 2019

The current fragmented regulatory approach to cannabis medicines across Europe is challenging to harmonize.

FDA Advances New Approach to Drug Quality Assessment

June 02, 2019

CDER’s KASA program seeks manufacturer data on drug attributes and risks to inform oversight.

FDA Faces Challenges After Gottlieb

May 02, 2019

New agency leadership is pressed to promote innovation while addressing safety and quality issues.

Continuous Manufacturing Gains Major Push from FDA

April 02, 2019

FDA is moving to shift industry away from step-wise batch production.

Cell and Gene Therapies Gain Streamlined FDA Oversight

March 02, 2019

FDA expects more than 200 investigational new drug applications for cell and gene therapies by 2020, causing the agency to strengthen its regulatory program.

FDA Promotes Quality Standards to Reduce Shortages

February 02, 2019

Policies emphasize the importance of ensuring data integrity in the United States and abroad.

FDA Sets Records in Approving More New Drugs

January 15, 2019

Industry investment and regulatory support combined to move many important new medicines to market.

CDER Priorities for 2019: Opioids, Quality, Safety, and Innovation

January 02, 2019

FDA plans to support initiatives to ensure that all medicines are safe, effective, and of high quality.

FDA Seeks to Revive Quality Metrics Initiative

July 02, 2018

The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.

Biosimilars Raise Manufacturing and Regulatory Challenges

July 02, 2018

FDA seeks more efficient testing to spur development of less costly biotech therapies.